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PC 360 Survivorship

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ClinicalTrials.gov Identifier: NCT03017456
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Vancouver Prostate Centre
McGill University Health Center
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with the goal of identifying and tracking unmet supportive care needs of patients with localized PC and responding to these needs through survivorship care. The current randomized control trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC) on patient activation (primary outcome) and access to services, self-Management support, satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS) will be used to electronically populate the survivorship care plans. Overall, this proposal represents initial steps in uniting the country in sharing programmatic resources, data, expertise, and enthusiasm to transform survivorship care for men with PC and their families.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Survivorship Care Plan Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Prostate Cancer Survivorship 360°
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
No Intervention: Usual Care (UC)
Patients in the UC arm will not receive the study intervention (behavioral) and instead will receive care according to usual practice. This usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and physical examination related to surgical/radiation recovery, review of the pathology and general instructions regarding the next step in follow-up.
Active Comparator: SCP-Intervention vs usual care
behavioral intervention vs control Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse. The SCP-Int is comprised of a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP). Persistent effects and concerns that are identified will prompt the development of a tailored management plan captured within the PC-SCP. Relevant patient education materials will be linked electronically. Nurses will use motivational interviewing techniques to effective in increase healthy behaviors and empower the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support.
Behavioral: Survivorship Care Plan
SCP-Intervention: Patients in the SCP-Int arm will attend a one-time appointment with a trained oncology nurse while the patients in the UC arm will receive care according to the hospital standards for follow-up care. The intervention will be delivered during a regular follow-up appointment, face-to-face and will inform and educate patients on self-management and support as well as promote access to and coordination of post-treatment care. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of "active behavior change ingredients" including the integration of motivational interviewing techniques which are effective in increasing healthy behaviors.
Other Name: PC 360-SCP




Primary Outcome Measures :
  1. Changes in the Patient Activation measure questionnaire [ Time Frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention. ]

Secondary Outcome Measures :
  1. Changes in the Health and Social Services Utilization Inventory [ Time Frame: change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention. ]
  2. Changes in the Health Education Impact Questionnaire [ Time Frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention. ]
  3. Changes in the Quality of Life INFO25 module [ Time Frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention. ]
  4. Changes in the Expanded Prostate Cancer Index Composite [ Time Frame: Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention. ]
  5. Changes in the Assessment of Survivors Concerns measure [ Time Frame: baseline (prior to intervention), 6 months post intervention, 12 months post intervention. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed localized (T1-T3N0M0) PC
  • age at diagnosis >18 years
  • treated with curative intent
  • treatment received >1 month and <6 months
  • disease-free as defined by absence of somatic disease activity parameters as per oncologist/urologist
  • consented to participate in the PC360-IS database.

Exclusion Criteria:

  • Patients who do not receive treatment and are followed by active surveillance
  • inability to complete study questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017456


Contacts
Contact: Jennifer M Jones, PhD 4165818603 jennifer.jones@uhn.ca
Contact: Charmaine A Silva, MSc 4165818453 charmaine.silva@uhn.ca

Locations
Canada, British Columbia
Vancouver Prostate Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Maria Spillane, MSc    604-875-4111 ext 62338    mspillane@prostatecentre.com   
Canada, Ontario
University Health Network - Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Charmaine Silva, MSc    4165818453    charmaine.silva@uhn.ca   
Contact: Jennifer Jones, PhD    4165818603    jennifer.jones@uhn.ca   
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada, H3H 2R9
Contact: Shabnam Hamidi, PhD    438-402-7381    shabnam.hamidi@mail.mcgill.ca   
Sponsors and Collaborators
University Health Network, Toronto
Vancouver Prostate Centre
McGill University Health Center
Investigators
Principal Investigator: Jennifer M Jones, PhD Princess Margaret Cancer Centre, University Health Network

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03017456     History of Changes
Other Study ID Numbers: 15-5045-CE
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
Survivorship
Prostate Cancer
Survivorship Care Plan

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases